MDS-G21

Guidance on Requirements of
Shipments Clearance
at Ports of Entry

Version Number: 3.0

Version Date: 26/7/2018

This guidance document has been published after being

distributed for public comments dated on 1/5/2017 for 30 days.

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Table of Content
Introduction ..................................................................................................................................... 3
Purpose ........................................................................................................................................ 3
Scope……… ............................................................................................................................... 3
Background ................................................................................................................................. 3

Requirements ................................................................................................................................... 4
Required Documents ....................................................................................................................... 6
Flowchart ......................................................................................................................................... 9

Annexes ......................................................................................................................................... 10
Annex (1): Declaration of Conformity for the Shipment to Saudi Food and Drug Authority
Medical Devices Interim Regulation ......................................................................................... 11
Annex (2): Definitions & Abbreviations ................................................................................... 12
Annex (3): List of Changes on the Pervious Version ................................................................ 13

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Introduction

Purpose
The purpose of this guidance is to clarify the requirements to obtain shipment clearance for products
subject to SFDA/MDS regulation at the KSA POEs.

Scope………
This guidance is applicable to any importer wishes to clear shipments containing products subject
to SFDA/MDS regulation at the KSA POEs.

Background
In accordance with “The Law of Saudi Food and Drug Authority” issued by the Royal Decree
No.(M/6) issued on 25/1/1428 H, SFDA/MDS undertakes the responsibility of issuing shipment
clearance for products subject to its regulation according to the requirements specified in this
guidance document.

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Requirements
General 1 Regulated products included in this guidance shall NOT be imported
unless shipment clearance is obtained from the SFDA/MDS.

2 No person shall import used medical devices.

3 For products containing materials subject to the MOI’s control (such

as IVDs and chemicals) require MDIL from SFDA/MDS before the
referral to MOI.

4 Importers may request a classification for the products intended to be

imported, in order to know whether they are subject to SFDA/MDS
regulation or not. For more information, refer to the SFDA’s website.

Registration & 5 Importers of medical devices, for marketing purposes, shall have:
Licensing o establishment National Registry Number that is issued through
Requirements MDNR.
for Medical
o MDEL for importing medical devices for marketing purposes.
Devices
Imported for Healthcare facilities importing for their own use are not
Marketing required to have MDEL with condition that the shipment
Purposes quantity is not commercial.

6 Medical devices imported for marketing purposes shall have MDMA.

However, low-risk medical devices that are non-sterile and not having
measuring function require either listing in the MDNR or having
MDMA.

Product 7 If the shelf life of the product is:

Shelf Life o less than one year, it shall NOT be less than 25% of its shelf
life at the POE.
o more than one year, it shall NOT be less than 4 months of its
shelf life at the POE.

Storage and 8  Importers shall comply with the manufacturer’s instructions for the
Transportation storage, handling, and transport of products they import.
 Each shipment that requires specific temperature for transportation
and/or storage, according to the manufacturer instructions, shall
contain data logger (digital temperature indicator) activated from
the time of shipping.

Samples 9 SFDA/MDS withdraws random samples of imported shipments at

Withdrawal POEs in order of assessment or examination according to risk-based
studies and for testing and scientific evaluation purposes or suspension
cases (e.g. misleading medical claims, sterilization and labeling
malfunctioning, inappropriate environment conditions, or

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 counterfeit… etc.). However, SFDA neither bear any costs of those
samples nor costs of their testing in private labs.

Submitting to 10 Importers shall submit the documents specified in “REQUIRED

the SFDA DOCUMENTS” below for each shipment at any of the following
POEs:
1. King Khaled International Airport – Riyadh (RAP)
2. Riyadh Dry Port (RDP)
3. King Abdulaziz International Airport – Jeddah (JAP)
4. Jeddah Islamic Seaport – (JSP)
5. King Abdullah Seaport – Rabigh (RSP)
6. King Fahd International Airport – Dammam (DAP)
7. King Abdulaziz Seaport – Dammam (DSP)
8. King Fahd Causeway – Khobar (DBP)
9. Batha Port - Al Ahsa (BBP)
10. Haditha Port - Al Qurayyat (HBP).

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Required Documents
Required Documents Sample Note

1 Copy of Purchase Invoice -  It shall be authenticated by the

2 Bill Of Lading (B/L) or the Air
Waybill (AWB)
3 Declaration of Conformity
to SFDA Medical Devices Interim
Regulation
4 Copy of MDIL
chamber of commerce in the
country of origin
 It shall contain the invoice
number, manufacturer’s name,
products name, quantity, and unit
price
 Model/part numbers and
lot/serial numbers shall be
indicating in the invoice or
packing list
- -
Annex 1  Required only for medical
devices imported for marketing
purpose that are having MDMA
and/or listed in the MDNR.
 This declaration is different than
the declaration of conformity to
the regulation of one of the
GHTF countries (Australia,
Canada, Japan, the USA and the
EU/EFTA)
-  Required only for the following
products:
o Medical devices imported
for:
 Demonstration or
training purpose only.
(For more information,
refer to guidance
document MDS-G8)
 Clinical investigations
purpose.
 Personal use. (For more
information, refer to
guidance document
MDS-G15).
 National emergency
situations. (For more
information, refer to
guidance document
MDS-G14)

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 o Custom-made medical
devices not frequently
imported. (For more
information, refer to
guidance document MDS-
G15)

o Finished medical devices

imported for the purpose of
local manufacturing.

o Medical IVDs

o Non-medical IVDs. (For

more information, refer to
guidance document MDS-
G16)

o Biological therapeutic
products

o International quality and

efficiency samples. (For
more information, refer to
guidance document MDS-
G9)

o Distillation apparatuses
imported for healthcare
providers or medical
educational facilities . (For
more information, refer to
guidance document MDS-
G19)

o Chemicals (finished
products) used in medical
applications. (For more
information, refer to
guidance document MDS-
G12)
6 Research Products Importation -  Required only for medical
License devices and non-medical IVDs
intended for educational or non-
clinical research purposes (For
more information, refer to
guidance document MDS-G18)
Notes:

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1. Labeling (affixed on the product itself or the instruction for use) for medical devices
imported for marketing purpose shall:
 correspond to the submitted labeling in MDMA system
 contain a barcode for home-use medical devices and correspond to the
registered barcode in MDMA
 be available in Arabic for medical devices intended for use by lay person.
 not include the SFDA logo nor the Establishment National Registry Number
issued by the SFDA
 not include logo for any governmental body, unless the purchase order
requires that, except conformity marks (such as qulaity mark of SASO, GCC
conformity marking).

For more information about labeling requirements, please refer to guidance document
MDS-G10 entitled “Guidance on Labeling Requirements for Medical Devices”.

2. Dvices intended to be connected to an a/c power supply and imported for marketing
purpose shall operate at a frequency of 60 Hz.
3. Importers have two weeks for correction from the issuance date of the notice letter,
issued from the port.
4. In case the shipment requires specific temperature for transportation and/or storage
according to the manufacturer instructions, serial number of data logger (digital
temperature indicator) shall be indicated in the invoice, (B/L)/(AWB), packing list or
letter from the invoice issuer. The delivery of data logger (digital temperature
recorder) to the SFDA office at the POE, especially the air ports, speeds up the
shipments clearance process.
5. Shipments that meet certain criteria may be cleared faster and without inspection.
These criteria are related to the shipment storage requirements and the importer's
record of compliance with the shipments clearance requirements (annual assessment).
6. Importer have the right to object within two weeks from the date of shipment
rejection by providing an objection letter to the POE Department at SFDA/MDS.

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Flowchart
Start

Products intended to be imported shall

be subject to SFDA/MDS regulation

(Importers may apply for a classification

via SFDA website)

Importers shall submit the documents

specified in sections (1), (2) and (3) of
“REQUIRED DOCUMENTS” at one of
the specified POEs

Is the product
a medical device
and imported for
the marketing No
purpose?
Yes

The following is required:

 establishment National Registry
Number (MDNR).
 MDEL. Healthcare facilities are
exempt
 MDMA, excluding low-risk medical
devices that are non-sterile and not
having measuring function which
instead require listing in the MDNR

Importers shall submit the relevant

documents specified in section
(4) of “REQUIRED DOCUMENTS”

No Is the
medical device a
medical IVD?

Yes

Is the product
Importers shall submit the relevant No imported for the
documents specified in section (5) of purpose of education
“REQUIRED DOCUMENTS” or non-clinical
research?
Yes

Importers shall submit the relevant

documents specified in section (6) of
“REQUIRED DOCUMENTS”

End

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Annexes

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 Annex (1): Declaration of Conformity for the Shipment to Saudi Food and
Drug Authority Medical Devices Interim Regulation
[To be printed on Manufacturer Letterhead]

Manufacturer Name: ……………………………………..……………...…………………………

Manufacturer Identification Number Assigned by the SFDA: ……………………………………..
Manufacturer Address: ……………………………………..………………………………….…..
Invoice Number (optional): ……………………………………..…………………………………

I hereby declare that the medical device(s) identified below complies with the Medical Devices
Interim Regulation and its associated Implementing Rules and has been authorized by the SFDA
to be placed on the KSA market.

Authorized Representative Name: ………………………………….………………………….......

(Note: Not applicable for low-risk medical devices that are non-sterile and not having measuring function)

Importer Name: …………………………………………………………………………………….

# Medical Device Quantity Serial Number/ Medical Device Listing Medical Device Listing
Trade Name1 Batch Number National Registry Number National Registry Number
(issued by MDMA system)2 (issued by MDNR system)3
or
MDMA Application Number

1
2

…
1
Medical device trade name shall match the names mentioned in the invoice, the MDMA and the MDNR.
2
Not applicable for low-risk medical devices that are non-sterile and not having measuring function.
3
Applicable for low-risk medical devices that are non-sterile and not having measuring function.
Note: Additional devices may be attached as a list.

Authorised Signatory (on behalf of the manufacturer)

Name:
Position:
Date:
Signature:

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 Annex (2): Definitions & Abbreviations
KSA Kingdom of Saudi Arabia
SFDA Saudi Food and Drug Authority
MDS Medical Devices Sector
MOI Ministry of Interior
GCC Gulf Cooperation Council
SASO Saudi Standards, Metrology and Quality Organization
AR Authorized Representative
Medical Device means any instrument, apparatus, implement, machine, appliance,
implant, in vitro reagent or calibrator, software, material or other
similar or related article:
A. Intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specific
purpose(s) of:
o Diagnosis, prevention, monitoring, treatment or
alleviation of disease,
o Diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or handicap,
o Investigation, replacement, modification, or support of the
anatomy or of a physiological process,
o Supporting or sustaining life,
o Control of conception,
o Disinfection of medical devices,
o Providing information for medical or diagnostic purposes
by means of in vitro examination of specimens derived
from the human body;
and
B. Which does not achieve its primary intended action in or on
the human body by pharmacological, immunological or
metabolic means, but which may be assisted in its intended
function by such means.
Labeling means written, printed or graphic matter
A. Affixed to a product or any of its containers or wrappers.
B. Information accompanying a product, related to
identification, technical description.
C. Information accompanying a product, related to its use, but
excluding shipping documents.
MDMA Medical Devices Marketing Authorization
MDEL Medical Devices Establishment License
MDIL Medical Devices Importation License
POE Port of Entry

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 Annex (3): List of Changes on the Pervious Version

Number & Date Changes Description

of the Pervious Version
1.0  Changing in the text of sections (6), (7) and (8) of "Requirements".
17/9/2017
 Changing in the text of section (3) of "Required Documents".
 Adding sections (4) and (5) to "Notes" of "Required Documents".
 Changing in Annex (1).
2.0  Changing in the text of section (7) of “ Requirements”.
6/2/2018

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